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Completed

NCT Number: NCT04839978

Community Trial in the Cherokee Nation

The target population is students attending high schools in small rural towns in the 14 counties that partially or fully fall within the Cherokee Nation reservation. Following recruitment of 20 school-based clusters, clusters are allocated to either the intervention condition or delayed-intervention control condition using constrained randomization. Constrained randomization helps to ensure balanced cluster sizes as well as similar levels of risk between the intervention and control at baseline. Study participants include all 10th grade students enrolled in the participating study high schools and students will be followed into the first year after their expected graduation.

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Key information

Conditions

Opioid Abuse Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cherokee Nation Reservation

Tahlequah, Oklahoma, 74464, United States

About this study

The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tenth grade students enrolled in the participating high schools

Exclusion criteria

  • unable to understand written or verbal English

Inclusion criteria

for high schools:

  • Counties that partially or fully fall within the Cherokee Nation reservation
  • Town population of 3,000 or less
  • Class size between 30 to 100 students

Exclusion criteria

for high schools:

  • Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
  • Existence of a community drug prevention coalition

Treatment and study plan

Connect Program

Behavioral

The Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention will be supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drug free norms among all students. Follow-up of moderate to high-risk youth will be conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary.

Communities Mobilizing for Change and Action (CMCA)

Behavioral

The community-level intervention Communities Mobilizing for Change and Action (CMCA) will involve educating and organizing of adult volunteers and consent will be assumed by their participation. Trainings and tools will be provided, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention.

Primary outcomes

  1. Number of Days of Alcohol Use

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    The number of days of alcohol use in the past 30 days is compared between study arms.

  2. Number of Days of Heavy Alcohol Use

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    The number of days of heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours.

  3. Number of Days of Marijuana Use

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    The number of days of marijuana use in the past 30 days is compared between study arms.

  4. Number of Days of Opioid Misuse

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    The number of days of opioid drug misuse use in the past 30 days is compared between study arms.

Secondary outcomes

  1. Social Support From Parent/Caregiver

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Social support from parents/caregivers is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.

  2. Social Support From Friend

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Social support from a friend is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.

  3. Social Support From Teacher

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Social support from a teacher is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.

  4. Social Support From Other Adult

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Social support from an adult, other than a parent/caregiver or teacher, is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.

  5. Perceived Availability of Alcohol

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Ease or difficulty in accessing alcohol is assessed with 4 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.

  6. Perceived Availability of Marijuana

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Ease or difficulty in accessing marijuana is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.

  7. Perceived Availability of Prescription Opioids

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Ease or difficulty in accessing prescription opioids is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.

  8. Social Normative Beliefs About Alcohol Use

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people drinking alcohol. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval

  9. Social Normative Beliefs About Marijuana

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people using marijuana. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.

  10. Social Normative Beliefs About Prescription Opioids

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people missing prescription opioids. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.

  11. Self-Efficacy

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Self-efficacy is assessed with 3 items asking how easy or hard it would be for participants to ask for help or refuse alcohol or drugs. Responses given on a 4-point scale, where 1 = very easy and 4 = very hard. The total score is expressed as the mean across items and ranges from 1 to 4, with lower scores indicating increased self-efficacy.

  12. Normative Estimates of Peer Drug Use

    Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

    Normative estimates of peer drug use (alcohol, marijuana, prescription opioid misuse) are assessed with 3 items asking about how many of their peers in school used drugs in the past year. Possible responses are 1 = none or almost none, 2 = less than half, 3 = about half, 4 = more than half, and 5 = almost all or all. The total score is expressed as the mean across items and ranges from 1 to 5, with higher scores indicating higher normative estimates of peer drug use.

  13. Proportion of Participants With Alcohol Use 6 Months Post-Graduation

    Time frame: 6 Months Post-Graduation

    Model predicted proportion of participants with alcohol use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.

  14. Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation

    Time frame: 6 Months Post-Graduation

    Model predicted proportion of participants with heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.

  15. Proportion of Participants With Marijuana Use 6 Months Post-Graduation

    Time frame: 6 Months Post-Graduation

    Model predicted proportion of participants with marijuana use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.

  16. Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation

    Time frame: 6 Months Post-Graduation

    The number of participants reporting prescription opioid misuse in the past 30 days at the survey administered 6-month post-graduation.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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